Evaluate the Time of Pain Relief of Fast Acting Aspirin Versus Acetaminophen in Subjects Diagnosed With Sore Throat Pain

NCT ID: NCT01453400

Last Updated: 2018-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 177 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-27
• Study Completion Date: 2012-04-06

Brief Summary

This study is to evaluate the onset of relief provided by a single, oral dose of fast release aspirin 1000 mg compared to acetaminophen 1000 mg and placebo in subjects with sore throat pain.

Conditions

Pharyngitis

Keywords

aspirin; acetylsalicylic acid; pharyngitis; sore throat

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

Acetylsalicylic Acid (Aspirin, BAY1019036) + placebo

Intervention Type: DRUG

Single dose, 2 x 500 mg fast release aspirin tablets (1000 mg) + 2 x placebo acetaminophen caplets

Arm 2

Group Type: ACTIVE_COMPARATOR

Acetaminophen + placebo

Intervention Type: DRUG

Single dose, 2 x 500 mg Acetaminophen caplets (1000 mg) + 2 x placebo fast release Aspirin tablets

Arm 3

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Single dose, 2 x placebo Acetaminophen caplets + 2 x placebo fast release Aspirin tablets

Interventions

Acetylsalicylic Acid (Aspirin, BAY1019036) + placebo

Single dose, 2 x 500 mg fast release aspirin tablets (1000 mg) + 2 x placebo acetaminophen caplets

Intervention Type: DRUG

Acetaminophen + placebo

Single dose, 2 x 500 mg Acetaminophen caplets (1000 mg) + 2 x placebo fast release Aspirin tablets

Intervention Type: DRUG

Placebo

Single dose, 2 x placebo Acetaminophen caplets + 2 x placebo fast release Aspirin tablets

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy, ambulatory, male and female subjects ≥ 18 years of age
• Presence of sore throat due to upper respiratory tract infection (URTI)
• Onset of sore throat pain within six days of the screening period
• Baseline sore throat pain intensity score ≥ 60 mm on the Sore Throat Pain Intensity Scale
• Have a score ≥ 5 on the Tonsillopharyngitis Assessment
• Female subjects of childbearing potential who are currently sexually active must be using a medically acceptable form of birth control for at least one month prior to screening (three months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Nuvaring, Depo-Provera, or double-barrier and have a negative pregnancy test at screening/treatment period. Female subjects of non-childbearing potential must be amenorrheic for at least two years or had a hysterectomy and/or bilateral oophorectomy.
• Understand the pain rating assessments

Exclusion Criteria

• History of hypersensitivity to aspirin, salicylates, other nonsteroidal anti-inflammatory drugs, acetaminophen, opioid analgesics, and similar drugs
• Use of any "cold medication" (i.e. decongestants, antihistamines, expectorants, antitussives) within four hours preceding administration of the investigational product
• Use of any immediate release analgesic/antipyretic within four hours or use of any sustained release or long-acting analgesic/antipyretic within twelve hours preceding administration of the investigational product
• Consumption of alcoholic beverages, or foods and beverages containing xanthines within two hours prior to administration of the investigational product
• Use of any sore throat lozenges, sprays, cough drops, menthol-containing products within one hour preceding administration of the investigational product
• Presence of cough that causes throat discomfort
• Presence of mouth-breathing or any respiratory condition that, in the Investigator's judgment, could compromise breathing
• Evidence of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, or malignancies for which aspirin or acetaminophen is contraindicated
• Relevant concomitant disease such as medically uncontrolled asthma (exercise induced asthma is permitted), chronic sinusitis or nasal structural abnormalities causing greater than fifty percent obstruction
• History of gastrointestinal bleeding or perforation related to previous non-steroidal anti-inflammatory therapy.
• Current or past history of a bleeding disorder
• Self reported alcoholism or drug abuse within two years prior to screening or routine consumption of three or more alcohol containing beverages per day
• Habituation to analgesic drugs or tranquilizers (i.e., routine use of five or more times per week for greater than three weeks)
• Acute illness, local infection, or disease (other than URTI with pharyngeal infection) that can interfere with the conduct of the study
• Current use of blood thinning (anticoagulant), low dose aspirin, or steroid drug
• Has initiated treatment for depression within the past thirty days
• Females who are pregnant or lactating

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Storrs, Connecticut, United States

Countries

United States

References

Voelker M, Schachtel BP, Cooper SA, Gatoulis SC. Efficacy of disintegrating aspirin in two different models for acute mild-to-moderate pain: sore throat pain and dental pain. Inflammopharmacology. 2016 Feb;24(1):43-51. doi: 10.1007/s10787-015-0253-0. Epub 2015 Nov 24.

Reference Type: DERIVED

PMID: 26603742 (View on PubMed)

Other Identifiers

15772

Identifier Type: -

Identifier Source: org_study_id